PMID- 27619394 OWN - NLM STAT- MEDLINE DCOM- 20170707 LR - 20181113 IS - 1573-2568 (Electronic) IS - 0163-2116 (Print) IS - 0163-2116 (Linking) VI - 61 IP - 11 DP - 2016 Nov TI - Efficacy and Safety of Ribavirin with Sofosbuvir Plus Ledipasvir in Patients with Genotype 1 Hepatitis C: A Meta-Analysis. PG - 3108-3117 AB - BACKGROUND: Sofosbuvir and ledipasvir with or without ribavirin (RBV) regimens (SLR vs. SL) have exhibited promising results for the treatment of patients with hepatitis C virus (HCV) genotype 1 infection. AIM: To comprehensively compare the efficacy and safety of the SL and SLR regimen for the treatment of chronic HCV genotype 1 infections. METHODS: The Cochrane Library, PubMed, Web of Science, and EMBASE databases were searched. Only RCTs that compared the efficacy and safety of SL or SLR regimen for the treatment of chronic HCV genotype 1 infection were included. The primary outcome measures were the sustained virological response weeks 12 (SVR12) post-treatment and adverse events (AEs). RESULTS: Seven studies comprising 2601 patients were included. Compared with the SL regimen, SLR yielded a similar probability of having an SVR12 (RR 1.002, 95 % CI 0.998, 1.017, P = 0.780). Based on subgroup analyses, the addition of RBV to the 8-week SL regimen improved the SVR12 rate. However, the SLR regimen for 12 or 24 weeks did not show a superior SVR12 rate regardless of treatment history and the presence or absence of cirrhosis. The pooled incidence of AEs was higher in patients that received the SLR treatment regimen (RR 1.140, 95 % CI 1.095, 1.187, P = 0.000). CONCLUSIONS: The 12-week or 24-week SL regimen with a low incidence of AEs is as effective and well tolerated as the SLR regimen for the treatment of patients with chronic HCV genotype 1 infection. FAU - He, Qiu-Feng AU - He QF AD - Key Laboratory of Molecular Biology for Infectious Diseases (Ministry of Education), Institute for Viral Hepatitis, Department of Infectious Diseases, The Second Affiliated Hospital, Chongqing Medical University, NO76 Lin Jiang Road, Yu Zhong District, Chongqing, 400010, China. FAU - Zhang, Qiong-Fang AU - Zhang QF AD - Key Laboratory of Molecular Biology for Infectious Diseases (Ministry of Education), Institute for Viral Hepatitis, Department of Infectious Diseases, The Second Affiliated Hospital, Chongqing Medical University, NO76 Lin Jiang Road, Yu Zhong District, Chongqing, 400010, China. FAU - Zhang, Da-Zhi AU - Zhang DZ AD - Key Laboratory of Molecular Biology for Infectious Diseases (Ministry of Education), Institute for Viral Hepatitis, Department of Infectious Diseases, The Second Affiliated Hospital, Chongqing Medical University, NO76 Lin Jiang Road, Yu Zhong District, Chongqing, 400010, China. dzhzhang@yahoo.com. LA - eng PT - Journal Article PT - Meta-Analysis PT - Research Support, Non-U.S. Gov't PT - Review DEP - 20160912 PL - United States TA - Dig Dis Sci JT - Digestive diseases and sciences JID - 7902782 RN - 0 (Antiviral Agents) RN - 0 (Benzimidazoles) RN - 0 (Fluorenes) RN - 013TE6E4WV (ledipasvir) RN - 49717AWG6K (Ribavirin) RN - WJ6CA3ZU8B (Sofosbuvir) SB - IM MH - Antiviral Agents/*therapeutic use MH - Benzimidazoles/*therapeutic use MH - Drug Therapy, Combination MH - Fluorenes/*therapeutic use MH - Genotype MH - Hepacivirus/genetics MH - Hepatitis C, Chronic/*drug therapy MH - Humans MH - Ribavirin/*therapeutic use MH - Sofosbuvir/*therapeutic use MH - Sustained Virologic Response MH - Treatment Outcome PMC - PMC5067290 OTO - NOTNLM OT - Efficacy OT - Genotype 1 hepatitis C OT - Ledipasvir OT - Ribavirin OT - Safety OT - Sofosbuvir COIS- The authors declare that they have no conflict of interest. EDAT- 2016/10/19 06:00 MHDA- 2017/07/08 06:00 PMCR- 2016/09/12 CRDT- 2016/09/14 06:00 PHST- 2016/04/14 00:00 [received] PHST- 2016/08/23 00:00 [accepted] PHST- 2016/10/19 06:00 [pubmed] PHST- 2017/07/08 06:00 [medline] PHST- 2016/09/14 06:00 [entrez] PHST- 2016/09/12 00:00 [pmc-release] AID - 10.1007/s10620-016-4291-2 [pii] AID - 4291 [pii] AID - 10.1007/s10620-016-4291-2 [doi] PST - ppublish SO - Dig Dis Sci. 2016 Nov;61(11):3108-3117. doi: 10.1007/s10620-016-4291-2. Epub 2016 Sep 12.